Hand Hygiene of Kindergarten Children

Hand Hygiene Clinical Trial

Official title:

Hand Hygiene of Kindergarten Children: Understanding the Effect of Live Feedback on Hand Washing Behavior, Self-Efficacy and Motivation of Young Children

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05395988
• Other study ID #: Hand hygiene kindergarten
• Status: Enrolling by invitation
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: October 2022

Study information

• Verified date: May 2022
• Source: Otto-Friedrich-University Bamberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized controlled trial to further assess the impact of a digital intervention on hand hygiene of young children. Children in intervention kindergartens will see live instructions and feedback on their hand washing activity in reals-time / while washing hands. Aim of the study is to better understand behavior change of young children.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

Inclusion Criteria:

• children attending kindergarten

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Hand Hygiene
• Hand Washing

Intervention

Device:
• Digital hand washing instructions
Tablet displaying animated hand washing instructions
• Digital hand washing reward
Tablet displaying animated hand washing instructions and animated animals as reward

Locations

Country	Name	City	State
Finland	University of Turku	Turku
Germany	Otto-Friedrich-University Bamberg	Bamberg

Sponsors (2)

Lead Sponsor	Collaborator
Otto-Friedrich-University Bamberg	University of Turku

Countries where clinical trial is conducted

Finland,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Handwashing motivation of children (measured as soaping time by digital system).	Motivation of children, measured as soaping time (activity level) by digital system. Activity level is used as a proxy for motivation.	up to 3 months
Primary	Handwashing motivation of children (investigated with observation questionnaire for children in kindergarten)	Motivation of children, investigated with observation questionnaire (covering different steps of handwashing) of children while washing hands in kindergarten. In the observation questionnaire, each step of handwashing is rated on a scale (with highest number meaning highest compliance to handwashing instructions). Activity level (as measured by observation questionnaire) is used as a proxy for motivation.	up to 3 months
Primary	Self-efficacy of children (investigated with interviews with children)	Self-efficacy of children is measured in interviews with the children. The interview questionnaires for the children are based on Bandura's concept of self-efficacy. The scale that is used in the interview questionnaires is specially developed for our experiment.	up to 3 months
Primary	Self-efficacy of children (investigated with interviews with staff)	Self-efficacy of children is measured in interviews with the kindergarten staff. The interview questionnaires for the staff (for evaluating children's self-efficacy) are based on Bandura's concept of self-efficacy. The scale that is used in the interview questionnaires is specially developed for our experiment.	up to 3 months
Secondary	Sickness days of children (as recorded by kindergarten management)	Sickness days of children, recorded by kindergarten management on a daily basis.	Up to one year